The resources below were developed by the Advancing Safety Analytics (ASA) Initiative in an effort to identify considerations and evaluate proposed best practices around the application of interrogative methods towards various safety data sources.
Advancing Safety Analytics Assets
Advancing Safety Analytics Materials
FDA Adverse Event Reporting System (FAERS) and VigiBase® are two established databases for safety monitoring of medicinal products, recently complemented with the EudraVigilance Data Analysis System (EVDAS). Signals of disproportionate reporting (SDRs) can characterize the reporting profile of a drug, accounting for the distribution of all drugs and all events in the database. This study aims to quantify the redundancy among the three databases when characterized by two disproportionality-based analyses (DPA).
This paper reviews the current landscape of signal management and proposes a simplified, end-to-end framework while highlighting some best practices.